Single dose medicament delivery device

ABSTRACT

A medicament delivery device configured to provide a variable single dose of medicament is disclosed. The medicament delivery device includes a main body and a syringe arranged in the main body, wherein the syringe comprises a medicament. The medicament delivery device further includes a removable cap and a plunger rod operatively arranged to eject the medicament through a delivery member i.e. an injection needle attached to the syringe. Still further, the medicament delivery device includes a tubular member coupled to the plunger rod. The tubular member is configured to rotate during removing of the removable cap, and the rotation releases the plunger rod thereby allowing the plunger rod to travel a predetermined distance so as to prime the medicament delivery device.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/748,974 filed Jan. 30, 2018, which is a U.S. National PhaseApplication pursuant to 35 U.S.C. § 371 of International Application No.PCT/EP2016/066503 filed Jul. 12, 2016, which claims priority to SwedishPatent Application No. 1551080-3 filed Aug. 19, 2015. The entiredisclosure contents of these applications are herewith incorporated byreference into the present application.

TECHNICAL FIELD

This present disclosure relates to relates to medicament deliverydevices such as automatic injection devices that may be primed.

BACKGROUND

Unless otherwise indicated herein, the materials described in thissection are not prior art to the claims in this application and are notadmitted to be prior art by inclusion in this section.

In some situations, it is desirable for patients to be able toadminister drugs and medicament by themselves, e.g., without the needfor trained medical staff to administer the drugs. There are a number ofdifferent existing delivery devices with varying degrees of automaticfunctions. There are however a number of considerations to take intoaccount for medicament delivery devices that are to be used bynon-trained persons in view of safety (e.g., for the user and othersthat may come in contact with the device) as well as in view of handlingand operation.

In an example, for safety reasons many devices have been arranged with acover or other protection means that is manually or automaticallyactivated in order to, for example, protect persons from an injectiondelivery member i.e. injection needle, both before and after use of themedicament delivery device.

For some types of medicament enclosures and treatment schemes there is aneed to deliver a precise dose, which may be less than the total amountin the enclosure. Further, in some circumstances, it is also desirableto perform a priming procedure of the device and/or delivery member i.e.injection needle before dispensing the medicament. Many devices areprovided with medicament enclosures such as cartridges, ampoules orsyringes containing medicament in liquid form. When filling thesecontainers with liquid, a small amount of air is often entrapped in thecontainer and this air should be removed before delivery. Some devicesare of multi-chamber type where one component is powder and the other isliquid or two liquids or more liquids and powder chambers.

SUMMARY

A medicament delivery device configured to administer a variable singledose of medicament is provided. In an example embodiment, the medicamentdelivery device includes a main body and a syringe arranged in the mainbody, wherein the syringe comprises a medicament. Further, themedicament delivery device includes a delivery member shield unitslidably arranged in the main body, a removable cap releasably coupledto the delivery member shield unit, and a plunger rod operativelyarranged to eject the medicament through a delivery member e.g. aninjection needle attached to the syringe. Still further, the medicamentdelivery device includes a tubular member arranged inside the deliverymember shield unit, wherein the tubular member is coupled to the plungerrod, and wherein the tubular member comprises a track. The deliverymember shield unit comprises a pin configured to interact with the trackof the tubular member. During removing of the removable cap, the pin onthe delivery member shield unit travels in the track on the tubularmember so as to cause rotation of the tubular member, wherein therotation releases the plunger rod thereby allowing the plunger rod totravel a predetermined distance so as to prime the medicament deliverydevice.

In another example embodiment, the medicament delivery device includes amain body and a syringe arranged in the main body, wherein the syringecomprises a medicament. The medicament delivery device further includesa removable cap and a plunger rod operatively arranged to eject themedicament through a delivery member e.g. an injection needle attachedto the syringe. Still further, the medicament delivery device includes atubular member coupled to the plunger rod. The tubular member isconfigured to rotate during removing of the removable cap, and therotation releases the plunger rod thereby allowing the plunger rod totravel a predetermined distance so as to prime the medicament deliverydevice.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the figures and the followingdetailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments are described herein with reference to thedrawings, in which:

FIG. 1 illustrates an example medicament delivery device, according toan example embodiment of the present disclosure.

FIG. 2 a illustrates a top cross-sectional view of the medicamentdelivery device of FIG. 1 , according to an example embodiment of thepresent disclosure.

FIG. 2 b illustrates a side cross-sectional view of the medicamentdelivery device of FIG. 1 , according to an example embodiment of thepresent disclosure.

FIG. 3 illustrates an exploded view of the medicament delivery device ofFIG. 1 , according to an example embodiment of the present disclosure.

FIG. 4 illustrates a cross-sectional view of the distal end of themedicament delivery device of FIG. 1 , according to an exampleembodiment of the present disclosure.

FIG. 5 illustrates example components of the medicament delivery deviceof FIG. 1 , according to an example embodiment of the presentdisclosure.

FIG. 6 illustrates example components of the medicament delivery deviceof FIG. 1 during a dose setting operation, according to an exampleembodiment of the present disclosure.

FIG. 7 illustrates a cross-sectional view of the distal end of themedicament delivery device of FIG. 1 , according to an exampleembodiment of the present disclosure.

FIG. 8 illustrates the medicament delivery device of FIG. 1 during adose setting operation, according to an example embodiment of thepresent disclosure.

FIG. 9 illustrates example components of the medicament delivery deviceof FIG. 1 during a dose setting operation, according to an exampleembodiment of the present disclosure.

FIG. 10 illustrates example components of the medicament delivery deviceof FIG. 1 during a dose setting operation, according to an exampleembodiment of the present disclosure.

FIG. 11 illustrates example components of the medicament delivery deviceof FIG. 1 during removal of the cap, according to an example embodimentof the present disclosure.

FIG. 12 illustrates example components of the medicament delivery deviceof FIG. 1 during removal of the cap, according to an example embodimentof the present disclosure.

FIG. 13 illustrates example components of the medicament delivery deviceof FIG. 1 during removal of the cap, according to an example embodimentof the present disclosure.

FIG. 14 illustrates example components of the medicament delivery deviceof FIG. 1 during removal of the cap, according to an example embodimentof the present disclosure.

FIG. 15 illustrates the example medicament delivery device of FIG. 1during medicament delivery, according to an example embodiment of thepresent disclosure.

FIG. 16 illustrates example components of the medicament delivery deviceof FIG. 1 during medicament delivery, according to an example embodimentof the present disclosure.

FIG. 17 illustrates example components of the medicament delivery deviceof FIG. 1 during medicament delivery, according to an example embodimentof the present disclosure.

FIG. 18 illustrates example components of the medicament delivery deviceof FIG. 1 , according to an example embodiment of the presentdisclosure.

FIG. 19 illustrates example components of the medicament delivery deviceof FIG. 1 during medicament delivery, according to an example embodimentof the present disclosure.

FIG. 20 illustrates example components of the medicament delivery deviceof FIG. 1 during medicament delivery, according to an example embodimentof the present disclosure.

FIG. 21 illustrates example components of the medicament delivery deviceof FIG. 1 during medicament delivery, according to an example embodimentof the present disclosure.

FIG. 22 illustrates example components of the medicament delivery deviceof FIG. 1 during removal of the device from the medicament deliverysite, according to an example embodiment of the present disclosure.

FIG. 23 illustrates example components of the medicament delivery deviceof FIG. 1 during removal of the device from the medicament deliverysite, according to an example embodiment of the present disclosure.

FIG. 24 illustrates example components of the medicament delivery deviceof FIG. 1 during removal of the device from the medicament deliverysite, according to an example embodiment of the present disclosure.

FIG. 25 is a cross-sectional perspective view of a main body of themedicament delivery device of FIG. 1 , according to an exampleembodiment of the present disclosure.

FIG. 26 is a close-up view of axial stop ribs and radial guiding ribs ofthe main body of FIG. 25 , according to an example embodiment of thepresent disclosure.

FIG. 27 is a cross-sectional perspective view of a syringe housingconnected to the main body of FIG. 25 , according to an exampleembodiment of the present disclosure.

FIGS. 28 a-b depict a perspective view of a removable cap of themedicament delivery device of FIG. 1 and a cross-sectional perspectiveview of the removable cap, respectively, according to an exampleembodiment of the present disclosure.

FIG. 29 is a cross-sectional perspective view of the removable cap ofFIGS. 28 a-b connected to a delivery member cover, according to anexample embodiment of the present disclosure.

FIG. 30 is a cross-sectional perspective view of the removable cap ofFIGS. 28 a-b connected to a main body, according to an exampleembodiment of the present disclosure.

FIG. 31 is a cross-sectional perspective view of the removable cap ofFIGS. 28 a-b connected to an RNS remover, according to an exampleembodiment of the present disclosure.

FIG. 32 is a perspective view of a delivery member cover of themedicament delivery device of FIG. 1 , according to an exampleembodiment of the present disclosure.

FIG. 33 is a perspective view of a delivery member shield link of themedicament delivery device of FIG. 1 , according to an exampleembodiment of the present disclosure.

FIG. 34 is a perspective view of a plunger rod of the medicamentdelivery device of FIG. 1 , according to an example embodiment of thepresent disclosure.

FIG. 35 a illustrates example components of the medicament deliverydevice of FIG. 1 when the dose knob is positioned at a first selectabledose, according to an example embodiment of the present disclosure.

FIG. 35 b illustrates example components of the medicament deliverydevice of FIG. 1 when the dose knob is positioned at a second selectabledose, according to an example embodiment of the present disclosure.

FIGS. 36 a-c depict example cross-sectional views taken at the dose knobof the medicament delivery device of FIG. 1 , according to an exampleembodiment of the present disclosure.

FIG. 37 depicts a perspective view of the rear shell of the medicamentdelivery device of FIG. 1 , according to an example embodiment of thepresent disclosure.

FIG. 38 illustrates an example separating rib, according to an exampleembodiment of the present disclosure.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented herein. It will be readily understood that the aspects of thepresent disclosure, as generally described herein, and illustrated inthe figures, can be arranged, substituted, combined, separated, anddesigned in a wide variety of different configurations, all of which areexplicitly contemplated herein.

The disclosed medicament delivery device provides a safe, intuitive anduser-friendly device for delivering a dose of medicament. In accordancewith example embodiments of the present disclosure, a medicamentdelivery device is configured to deliver a variable single dose ofmedicament subcutaneously from a preinstalled and prefilled syringe. Thedose is set prior to removing the cap of the medicament delivery device.During removal of the cap, the autoinjector is automatically primed.Further, the medicament delivery is activated by the user when thedelivery member cover is pressed on the medicament delivery site. Aftermedicament delivery of the dose of medicament, the medicament deliverydevice automatically locks the delivery member cover to prevent e.g.needle stick injuries and the autoinjector is disposed.

FIG. 1 generally illustrates an example medicament delivery device 100that is capable of setting and delivering a variable single dose ofmedicament. In particular, FIG. 1 illustrates medicament delivery device100 in an initial state prior to medicament delivery. Further, FIG. 2 aillustrates a top cross-sectional view of medicament delivery device 100in the initial state, and FIG. 2 b illustrates a side cross-sectionalview of medicament delivery device 100 in the initial state.

With reference to FIGS. 1 and 2 a-b, medicament delivery device 100includes a main body 102 and a syringe 104 arranged in the main body102. The syringe 104 includes a syringe body 106 holding a medicament108, a delivery member i.e. an injection needle 110, and a rigid needleshield (RNS) 112 covering the delivery member i.e. the injection needle110. A piston 114 is disposed in the syringe body 106. The medicamentdelivery device 100 further includes a plunger rod 116 operativelyarranged to eject the medicament 108 through the delivery member i.e.the injection needle 110 attached to the syringe 104.

Even though a syringe 104 is described in this example embodiment ofFIG. 1 , any suitable type of medicament 108 containing enclosure may beused in the disclosed medicament delivery device 100, such as a syringe,an ampoule, a cartridge, a container, etc. Further, the medicament maybe any suitable substance used for medical treatment. In an exampleembodiment, the medicament is Sumatriptan, which may be used formigraine treatment.

Even though an automatic injection device is described in this exampleembodiment of FIG. 1 , any suitable type of medicament delivery device100 having a suitable delivery member 110 may be used in the disclosedmedicament delivery device 100.

A delivery member shield unit 118 is slidably arranged in the main body102. In this example, the delivery member shield unit 118 includes adelivery member cover 120 and a delivery member shield link 122. Atubular member 124 (hereinafter referred to as a “rotator”) is arrangedinside the delivery member shield unit 118. The rotator 124 is coupledto the plunger rod 116. Further, a dose knob 126 is disposed at aproximal end 128 of the medicament delivery device 100 and is configuredto rotate with respect to the main body 102 for setting a dose of themedicament 108. Still further, a dose stop 130 is configured to rotatewith the dose knob 126. In addition to being coupled to the dose knob126, the dose stop 130 is coupled to the delivery member shield unit118. For instance, the dose stop 130 includes an engagement featureconfigured to engage with a corresponding engagement feature on thedelivery member shield unit 118.

A removable cap 132 is disposed on a distal end 134 of the medicamentdelivery device 100. The removable cap 132 is releasably coupled to thedelivery member shield unit 118 and is configured to be locked prior toa dose of the medicament 108 being set and to be unlocked when a dose ofthe medicament 108 is set. For instance, prior to a dose of themedicament 108 being set, the delivery member shield unit 118 and theremovable cap 132 are axially locked with respect to the main body 102.Further, after a dose of the medicament 108 is set, the delivery membershield unit 118 and the removable cap 132 are unlocked and are axiallymoveable with respect to the main body 102.

FIG. 3 illustrates an exploded view of medicament delivery device 100.This exploded view shows example components of medicament deliverydevice 100. The component parts of medicament delivery device 100include the following components: cap 132, rigid needle shield (RNS)remover 140, main body (e.g., front shell) 102, delivery member cover120, front shell frame 142, syringe housing 144, syringe 104, rotator124, delivery member shield link 122, dose stop 130, delivery membercover spring 146, rear shell clip 148, rear shell 150, plunger rod 116,plunger rod spring 152, spring guide rod 154, dose knob 126, and backlid 156. It should be understood that the illustrated components areintended as an example only. In other example embodiments, fewercomponents, additional components, and/or alternative components arepossible as well.

In order to administer a dose of medicament 108 from medicament deliverydevice 100, a user (i) sets a dose, (ii) removes the cap, (iii) placesthe device on the medicament delivery site 211, and (iv) presses thedevice against the medicament delivery site 211. In an exampleembodiment, during removal of the removable cap 132 from the medicamentdelivery device 100, the medicament delivery device 100 is primed. Aftermedicament delivery is complete, the user then removes the device fromthe medicament delivery site 211. The delivery member cover 120 mayaxially extend and lock in the extended position so as to limit orprevent e.g. needle stick injury.

As shown in FIG. 1 , medicament delivery device 100 includes a window160 in the main body 102. In an example embodiment, prior to medicamentdelivery of the variable single dose of medicament 108, the medicament108 and at least part of the stopper 114 is visible through the window160. Prior to medicament delivery, a user may inspect the medicament 108through the window 160. The ability to inspect the medicament 108through window 160 may help to increase the safety of the medicamentdelivery device 100. For example, this ability may help the user confirmthat the medicament delivery device 100 contains a dose of themedicament 108. This ability may also help the user confirm that themedicament delivery device 100 contains the correct type of medicament108 that the user intends to deliver.

In this initial state prior to a dose of the medicament 108 being set,the delivery member shield unit 118 and the removable cap 132 areaxially locked with respect to the main body 102. By being axiallylocked with respect to the main body 102, a user would be unable toremove the cap 132 and thus would be unable to administer a dose.However, by setting a dose of the medicament 108, the cap 132 isunlocked and the user is then able to remove the cap 132 from the device100 in order to administer the dose.

The removable cap 132 and its interaction with other various componentsof the medicament delivery device 100 is described in greater detailwith reference to FIGS. 4-7 .

During removal of the cap 132, the cap 132 acts to remove the RNS 112covering the delivery member i.e. an injection needle of the syringe104. FIG. 4 illustrates a close-up view of the distal end 134 of themedicament delivery device 100. As seen in FIG. 4 , in the initialstate, RNS remover 140 is fastened to the removable cap 132. The RNSremover 140 includes a first engagement feature 170 for coupling to theremovable cap 132 and a second engagement feature 172 for coupling tothe RNS 112. In an example embodiment, the first engagement feature 170is a snap-fit feature and the second engagement feature 172 is a prong.The removable cap 132 is free to rotate without rotating the RNS remover140. Therefore, prior to setting a dose, a user may rotate the removablecap 132 but the user will be unable to remove the cap 132 from thedevice 100. However, in another example embodiment, the removable cap132 is locked rotationally in addition to being locked axially.

FIG. 5 illustrates example components that are configured to lock themedicament delivery device 100 when a dose is not set. Removable cap 132is connected to delivery member shield unit 118, and delivery membershield unit 118 is connected to dose stop 130. As shown in FIG. 5 ,delivery member shield unit 118 includes delivery member cover 120 whichis connected to delivery member shield link 122, and removable cap 132is connected to delivery member cover 120 while delivery member shieldlink 122 is connected to dose stop 130. Dose stop 130 includes anengagement feature such as outwardly protruding element 180 configuredto engage with a corresponding engagement feature on the delivery membershield link 122 such as an inwardly protruding element 182. Prior to adose being set, outwardly protruding element 180 and inwardly protrudingelement 182 engage one another and prevent axial movement of thedelivery member shield unit 118 with respect to the dose stop 130. Thisengagement locks the removable cap 132 such that the removable cap 132cannot be removed from the medicament delivery device 100.

As mentioned above, dose stop 130 is configured to rotate with the doseknob 126. For instance, when a user rotates dose knob 126 to set a dose,dose stop 130 also rotates a corresponding amount. Setting the dose viadose knob 126 causes the outwardly protruding element 180 to be movedout of engagement with the inwardly protruding element 182, so as torelease the engagement between the dose stop 130 and the delivery membershield unit 118. This release of the engagement between the dose stop130 and the delivery member shield unit 118 is depicted in FIG. 6 . Inparticular, FIG. 6 illustrates outwardly protruding element 180 movedout of engagement with the inwardly protruding element 182. After theseelements have been moved out of engagement with each other, the device100 is unlocked and the removable cap 132 and delivery member shieldunit 118 are movable in the distal direction indicated by arrow 183. Inorder to move the cap 132 and the delivery member shield unit 118, auser may pull on the cap 132 in distal direction 183.

The removable cap 132 may also include engagement features that interactwith the main body 102 to facilitate further engagement of the removablecap 132 to the device. FIG. 7 illustrates another close up of the distalend 134 of the medicament delivery device 100. Tabs 184 on the removablecap 132 lock against the inside surface 186 of the main body 102 whenthe device is locked. However, when the removable cap 132 and thedelivery member shield unit 118 are unlocked, this engagement betweencap 132 and the main body 102 may be overcome by a user pulling the cap132 in the distal direction 183.

In an example embodiment, the medicament delivery device 100 includes avisual indication 174 that serves to indicate that the delivery membershield unit 118 and the removable cap 132 are axially locked. Forinstance, as shown in FIG. 1 , visual indication 174 is visible througha window 176 in the dose knob 126. While this visual indication 174 isan illustration of a lock, any suitable visual indication to illustratethat the device is locked is possible. The medicament delivery device100 also includes visual indication 178 that indicates a movement thatis capable of unlocking the medicament delivery device 100.

The process of setting the dose is described further with reference toFIGS. 8-10 . With reference to FIG. 8 , a user selects a dose by turningthe dose knob 126 a given amount (e.g., 45 degrees) for a first dosevalue (e.g., a 3 mg dose) or a second given amount (e.g., 90 degrees)for a second dose value (e.g., a 6 mg dose). The user may dial back andforth between the various selectable doses and the locked position. As auser sets a dose and unlocks the medicament delivery device 100, thedose knob window 176 moves and covers up the visual indication 174 toreveal a dose value (as can be seen by comparing FIG. 1 and FIG. 8 ).Thus, the user would be aware that the device is unlocked and that adose has been set.

In an example, the user turns the dose knob 126 clockwise to change fromthe locked position to a set dose position. However, in another example,the user turns the dose knob 126 counterclockwise to change from thelocked position to a set dose position. Further, although the dose knob126 is shown as being rotatable in order to set a dose, in other exampleembodiments the medicament delivery device is configured such that othermotions (e.g., axial movement) may be used to set a dose.

As mentioned above, setting a dose unlocks the medicament deliverydevice 100 so that the removable cap 132 and the delivery member shieldunit 118 are axially moveable. In an example, the engagement between thedelivery member shield unit 118 and the dose stop 130 is fully releasedonce the first selectable dose is reached. For instance, in an examplewhere the user is able to select between a first selectable dose and asecond selectable dose (e.g., a 3 mg dose and a 6 mg dose), theengagement between the delivery member shield unit 118 and the dose stop130 is released when the first selectable dose (e.g., the 3 mg dose) isselected.

In addition to unlocking the cap 132 by causing the outwardly protrudingelement 180 to be moved out of engagement with the inwardly protrudingelement 182 (as shown in FIG. 6 ), dialing the dose via dose knob 126also positions the dose stop 130 in the correct position for the device100 to administer the set dose. In an example embodiment, the dose stop130 has pockets in its inside surface that serve to, during medicamentdelivery, stop the plunger rod 116 travel for the selected dose. Examplepockets are shown in FIG. 9 , which depicts a perspectivecross-sectional view of plunger rod 116, dose stop 130, and dose knob126. As shown in FIG. 9 , dose stop 130 includes a pocket formed by stoprib 190 and a pocket formed by stop rib 192. Each stop rib correspondsto a different size of dose. For instance, stop rib 190 corresponds tothe first dose value (e.g., a 3 mg dose) and stop rib 192 corresponds tothe second dose value (e.g., a 6 mg dose).

Plunger rod 116 is radially locked with respect to the main body 102 andincludes a protrusion 194 that is configured to interact with the stopribs 190, 192 of the dose stop 130. FIG. 9 depicts the medicamentdelivery device 100 before the dose knob 126 is turned to the first dosevalue. In particular, the protrusion 194 is just about to line up withthe pocket comprising stop rib 190. FIG. 10 depicts the medicamentdelivery device 100 when the dose knob 126 is fully turned to the firstdose value. In this position where the dose knob 126 is at the firstdose value, the plunger rod 116 will be able to move distally duringmedicament delivery as indicated by arrow 196 until the protrusion 194reaches stop rib 190. Further, if dose knob 126 were rotated to thesecond dose value, protrusion 194 would line up with stop rib 192 ratherthan stop rib 190. This would allow the device to deliver the largersecond dose value. The dose medicament delivery process will bedescribed in greater detail below.

Prior to delivering the dose, the removable cap 132 is removed from themedicament delivery device 100. As mentioned above, after setting thedose, the removable cap 132 is unlocked and can be removed. In order toremove the cap 132 from the medicament delivery device 100, a user maypull the removable cap 132 in a distal direction 183. This pullingaction will cause both the cap 132 and delivery member shield unit 118to move in the distal direction 183. At a given point, the deliverymember shield unit 118 will reach a travel limit. In an example, thedelivery member shield unit 118 includes an axial stop that limits thedistal travel of the delivery member shield unit 118. The user maycontinue to pull the cap 132 in the distal direction 183 and thismovement will cause the removable cap 132 to disengage from the deliverymember shield unit 118.

Removing the cap 132 will also remove the RNS 112 from the syringe 104.In particular, as shown in FIG. 4 , prongs on the RNS remover 140interact with corresponding engagement features on the RNS 112. When thecap 132 is moved in the distal direction 183, the prongs and thecorresponding engagement features remain engaged and thus the RNS 112 isremoved when the cap 132 is removed. By removing the RNS 112 from thesyringe 104, a delivery member, i.e. an injection needle 110 will beaccessible for piercing the medicament delivery site 211 after themedicament delivery process is initiated.

Further, in an example embodiment, this action of removing the cap 132will cause the medicament delivery device 100 to be automaticallyprimed. By automatically priming the device during this removal action,the user will not need to undertake a separate action to prime thedevice, thereby improving both ease of operation of the device andsafety of the device. In an example embodiment, pins 202 on the insideof the delivery member shield link 122 travel in a track 200 on therotator 124 that cams and turns the rotator 124. The rotation of therotator 124 releases the plunger rod 116 which is resting on shelves onthe inside of the rotator 124. The plunger rod 116 travels a presetdistance to a next set of shelves. After this automatic priming, thedevice is ready for medicament delivery. In an example, priming of thedevice involves ensuring that the plunger rod 116 is in contact withstopper 114 so that the correct amount of the medicament 108 canexpelled from the device. In an example, in order to ensure that theplunger rod 116 is in contact with stopper 114, the medicament deliverydevice 100 is configured to expel expelling a priming portion of themedicament 108 from the medicament delivery device 100. An examplepriming portion is between 0.05 ml and 0.2 ml. However, other suitablepriming portions are possible as well.

This automatic priming of the device is further described with referenceto FIGS. 11-14 . As shown in FIG. 11 , rotator 124 is arranged insidethe delivery member shield unit 118 and is coupled to the plunger rod116. Rotator 124 includes a track 200. The delivery member shield unit118 comprises a pin 202 configured to interact with the track 200 of therotator 124. During removing of the removable cap 132, the deliverymember shield unit 118 moves in the distal direction 183 and the pin 202on the delivery member shield unit 118 travels in a first portion 201 ofthe track 200 on the rotator 124 so as to cause rotation of the rotator124. The rotation releases the plunger rod 116 thereby allowing theplunger rod 116 to travel a predetermined distance so as to prime themedicament delivery device 100. In an example, the predetermineddistance is a distance between rib 208 and rib 210, which are eachdisposed on an inner surface of the tubular member 124. In particular,rotation of the rotator 124 moves the protrusion 206 on the plunger rod116 off of rib 208 (see FIG. 12 ). Plunger rod 116 is then able to move,under a force such as a spring force, distally in distal direction 183until protrusion 206 interacts with rib 210 (see FIGS. 13 and 14 ). Themovement of the plunger rod 116 in distal direction 183 will cause theplunger rod 116 to act on stopper 114 so as to prime the device.

In an example embodiment, after the removable cap 132 is removed and thedevice 100 is primed, the user is given the option to change betweendifferent selectable dose sizes but is prevented from returning the dosedial 126 to the zero dose, locked position. For instance, in the examplewhere the user is able to select between a first selectable dose and asecond selectable dose (e.g., a 3 mg dose and a 6 mg dose), the user maychange between the first selectable dose and the second selectable dose(e.g., a 3 mg dose and a 6 mg dose) after removing the cap 132. However,the user may be prevented from returning the dose knob 126 to go back tothe visual indication 174 (i.e., padlock symbol) (see FIG. 37 ) at thisstage, as the dose selecting mechanism may be configured to not allowsuch a movement.

This example embodiment is described further with reference to FIGS. 35a through 37. It should be understood that other arrangements arepossible as well. FIG. 35 a depicts various components of the medicamentdelivery device 100 when the dose knob 126 is positioned at the firstselectable dose after the removable cap 132 has been removed. Further,FIG. 35 b depicts when the dose knob 126 is positioned at the secondselectable dose after the removable cap 132 has been removed. Stillfurther, FIGS. 36 a-c depict section cut views of the dose knob 126showing the locked, first selectable dose, and second selectable doserespective positions. Yet still further, FIG. 37 shows a perspectiveview of the rear shell.

In particular, FIG. 35 a depicts delivery member shield link 122,rotator 124, dose stop 130, and dose knob 126. As indicated by arrow300, the dose knob 126 may be rotated to select the second selectabledose, but the dose knob 126 may not be rotated to the zero doseposition. The user can change to the second selectable dose (e.g., the 6mg dose) and cannot dial back to the locked state due to a rib on thedose stop 130 and the inside rib features on the radially lockeddelivery member shield link 122. Further, FIG. 35 b depicts when thedose knob 126 is positioned at the second selectable dose. As indicatedby arrow 302, the dose knob 126 may be rotated to select the firstselectable dose. However, the dose knob 126 may not be rotated to set ahigher dose or to the zero dose position. The user can change to thefirst selectable dose (e.g., the 3 mg dose) and cannot dial further asthe dose knob 126 bottoms out with rib features inside the rear shell.

FIGS. 36 a-c depict section cut views of the dose knob 126 showinglocked, first selectable dose, and second selectable dose respectivepositions. In these Figures, dose knob window position 310 is shown. Asshown in FIG. 36 a , in the locked position, the dose knob 126 can berotated as indicated by arrow 314. Further, as shown in FIG. 36 b ,after the cap is removed, the dose knob 126 can be rotated as indicatedby arrow 316. Further, as shown in FIG. 36 c , after the cap is removed,the dose knob 126 can change to the 3 mg dose and cannot dial further asthe dose knob 126 bottoms out with rib features inside the rear shell.Example rib features 304 and 306 are shown in FIG. 36 c , and an examplerear shell stop feature 308 is shown in FIGS. 36 a-c and 37.

In another example embodiment, after the removable cap 132 is removedand the device is primed, the set dose cannot be changed. In an example,a separating rib 318 can be added to lock the initially set dose so thatthe user cannot dial between the two doses after removing the cap 132.For instance, an example position for separating rib 318 is shown inFIG. 38 . Other arrangements are possible as well.

After the removable cap 132 is removed and the device is automaticallyprimed, the user may then initiate the medicament delivery process. Toinitiate the medicament delivery process, the user places the medicamentdelivery device 100 on an medicament delivery site 211, such asmedicament delivery site 211 as shown in FIG. 15 . The user manuallyinserts the delivery member i.e. an injection needle 110 into themedicament delivery site 211 and activates the device when the deliverymember cover 120 is pressed onto the medicament delivery site 211. Thedevice 100 is configured to automatically deliver the selected doseafter being activated by the user. FIGS. 16-21 depict example componentsof the medicament delivery device 100 during the medicament deliveryprocess.

As seen by comparing FIGS. 16-17 , the delivery member cover 120 whichis connected to the delivery member shield link 122 rotates the rotator124 as it moves axially in the proximal direction 212 (e.g., when theuser pushes the device against the medicament delivery site 211). Pin202 interacts with a second portion 214 of track 200 on the rotator 124.When the rotator 124 turns, the rotator 124 releases the plunger rod 116which is sitting on rib 210 inside the rotator 124 (this release can beseen by comparing FIGS. 18 and 19 ). When plunger rod 116 is no longerinteracting with rib 210, the plunger rod 116 can move in distaldirection 183 (as shown in FIG. 19 ). This movement in the distaldirection 183 will cause the dose of medicament 108 to be delivered.

FIGS. 20 and 21 show movement of the plunger rod 116 during dosedelivery. The plunger rod 116 will move the stopper 114 in the distaldirection 183 until the set dose is fully dispensed. At the beginning ofthe medicament delivery process, the protrusion 206 is interacting withthe priming rib 210. However, movement of the rotator 124 removes thisinteraction and the plunger rod 116 can move in the distal direction 183until the protrusion 194 interacts with the stop rib(s) for the selecteddose, such as stop rib 190 or 192. For instance, with reference to FIG.21 , protrusion 194 of the plunger rod 116 interacts with stop rib 190and this stops distal travel of the plunger rod 116. At this point, theselected dose has been delivered. In an example embodiment, during dosedelivery, the user can hear and/or feel an audible and/or/tactilefeedback (e.g., clicking) throughout the dose delivery.

After medicament delivery is complete, the device is removed from themedicament delivery site 211. In an example, the end of medicamentdelivery may be indicated by the audible/tactile clicking havingstopped. In another example embodiment, for at least some doses (e.g.,doses less than the maximum selectable dose), the stopper and plungerrod may be visible in the main body window when medicament delivery iscomplete. In such an example, the end of delivery may be indicated bythe plunger rod and plunger having stopped moving. In another example(e.g., when the highest possible dose is delivered), the stopper is nolonger visible through the main body window when medicament delivery iscomplete. In such an example, the device may be configured such that theend of delivery is indicated by the stopper no longer being visiblethrough the main body window. Other indications of dose delivery beingcomplete are possible as well.

After the user removes the medicament delivery device 100 from themedicament delivery site 211, the delivery member cover 120 will extendoutward and lock into place. This extension and locking may limit orprevent e.g. needle stick injuries. When the medicament delivery device100 is removed from the medicament delivery site 211, the deliverymember cover 120 automatically extends outward in the distal direction183 (e.g., under a force such as a spring force). As shown in FIGS.22-24 , a snap feature on the rotator 124 turns the rotator 124 enoughto position the delivery member shield link pins 202 against rigid ribson the rotator 124. Tabs 221 on the rotator 124 flex to the side whenthe delivery member shield link pin(s) 202 passes. Once the locking rib220 is cleared, the rotator 124 turns slightly so that the pins 202 arepositioned in front of the locking rib 220. This locks the deliverymember cover 120 into place so to prevent unintended e.g. needle stickinjuries. The user may then place cap 132 back on the medicamentdelivery device 100 and dispose of the medicament delivery device 100.Other ways of locking the delivery member cover 120 in an extendedposition are possible as well.

FIGS. 25-34 depict example components of the medicament delivery device100 in further detail as well as example interactions of the componentswith other components.

FIG. 25 is a cross-sectional perspective view of the main body 102. Mainbody 102 includes an edge 230 for cap snaps, axial stop ribs 234, andradial guiding ribs 236 for the front shell frame 142 and syringehousing 144. Main body 102 further includes radial locking rib 238 forthe rear shell, snap openings 240 for the syringe housing 144 and rearshell, and cutouts 242 for assembly of the rear shell. FIG. 26 is aclose-up view of axial stop ribs 234 and radial guiding ribs 236 of themain body 102. FIG. 27 is a cross-sectional perspective view of thesyringe housing 144 connected to the main body 102 via snap openings240.

FIGS. 28 a-b depict a perspective view of removable cap 132 and across-sectional perspective view of the removable cap 132, respectively.Removable cap 132 includes engagement feature 250 for the RNS remover140, engagement feature 252 for the delivery member cover 120, andengagement feature 184 for the main body 102. FIG. 29 is across-sectional perspective view of the removable cap 132 connected tothe delivery member cover 120 via engagement features 252. Inparticular, snap-fit engagement features 252 are connected tocorresponding snap-fit engagement features 253 on the delivery membercover 120. FIG. 30 is a cross-sectional perspective view of theremovable cap 132 connected to the main body 102 via engagement features184. FIG. 31 is a cross-sectional perspective view of the removable cap132 connected to the RNS remover 140 via engagement feature 250.

FIG. 32 is a perspective view of the delivery member cover 120. Deliverymember cover 120 includes engagement feature 260 for holding the capprior to cap removal and engagement feature 262 for holding the capafter medicament delivery. Further, delivery member cover 120 includesdelivery member cover guiding ribs 264, axial stop 266 for the deliverymember cover 120 extension, and delivery member shield link connectinginterface 268.

FIG. 33 is a perspective view of the delivery member shield link 122.Delivery member shield link 122 includes delivery member coverconnecting interface 270 and pin 202 for traveling and camming into therotator track 200. Delivery member shield link 122 also includesdelivery member cover springs seat 274 and spring feature 182 configuredto keep the dose stop 130 and delivery member shield link 122 togetherduring sub assembly.

FIG. 34 is a perspective view of the plunger rod 116. Plunger rod 116includes radial guidance 280, as well as protrusion 206 for priming andprotrusion 194 interacting with dose stop ribs 190, 192.

As mentioned above, the medicament delivery device of the presentdisclosure is configured to deliver a variable single dose of medicament108. In the example shown in the Figures, the medicament delivery device100 is configured to allow the user to select either a first dose or asecond dose. However, in other embodiments, the medicament deliverydevice could be configured to allow the user to select fewer doses ormore doses. For instance, in an example embodiment, the user is able toselect a (non-variable) single dose. In other example embodiments, theuser is able to select three different doses, four different doses, fivedifferent doses, and so forth.

The embodiment described above is an automatic injector. The deliverymechanism of the automatic injector may be powered by a suitablemechanism such as a spring, compressed gas, or electrical energy.Further, in other embodiments, the medicament delivery device is amanual injector where the delivery mechanism is powered by a manualaction of the user.

Further, various engagement features for are shown for providing anengagement between one or more components of the medicament deliverydevice. The engagement features may be any suitable connecting mechanismsuch as a snap lock, a snap fit, form fit, a bayonet, lure lock, threadsor combination of these designs. Other designs are possible as well.

As mentioned above, removing the cap may act to automatically prime themedicament delivery device. Additionally or alternatively, removing thecap may perform other actions. For instance, in an example where thedevice is a dual chamber device having two different medicaments thatare separated prior to medicament delivery, removing the cap may act tomix the medicaments. For example, removing the cap may cause the plungerto move a stopper inside the cartridge to a position where twosubstances contained in the cartridge, and initially held separated fromeach other by the stopper, are mixed. Other example actions uponremoving the cap are possible as well.

It is to be understood that the above described and shown embodiment ofthe present disclosure is to be regarded as a non-limiting example andthat it can be modified within the scope of the claims.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopebeing indicated by the following claims, along with the full scope ofequivalents to which such claims are entitled. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting.

The invention claimed is:
 1. A medicament delivery device comprising: amain body; a cartridge arranged in the main body, wherein the cartridgecomprises a medicament; a delivery member shield unit slidably arrangedin the main body; a removable cap directly abutting the delivery membershield unit; a plunger rod operatively arranged to eject the medicamentthrough a delivery member attached to the cartridge; and a tubularmember arranged inside the delivery member shield unit, where thetubular member comprises a track and is coupled to the plunger rod,wherein the delivery member shield unit comprises a pin configured tointeract with the track of the tubular member, and wherein, duringremoval of the removable cap, the pin on the delivery member shield unittravels in the track on the tubular member so as to cause rotation ofthe tubular member that releases the plunger rod thereby allowing theplunger rod to travel a predetermined distance so as to automaticallyprime the medicament delivery device.
 2. The medicament delivery deviceof claim 1, wherein the tubular member comprises a first rib and asecond rib, and wherein the predetermined distance is a distance betweenthe first rib and the second rib.
 3. The medicament delivery device ofclaim 2, wherein the first rib and the second rib are disposed on aninner surface of the tubular member.
 4. The medicament delivery deviceof claim 2, wherein the plunger rod comprises a protrusion configured tointeract with the first rib, and wherein the rotation of the tubularmember moves the protrusion on the plunger rod off of the first rib. 5.The medicament delivery device of claim 4, further comprising a springconfigured to, after the rotation of the tubular member moves theprotrusion on the plunger rod off of the first rib, move the plunger rodin a distal direction until the protrusion interacts with the secondrib.
 6. The medicament delivery device of claim 5, wherein the cartridgecomprises a stopper, and wherein movement of the plunger rod in thedistal direction causes the plunger rod to act on the stopper so as toprime the medicament delivery device.
 7. The medicament delivery deviceof claim 1, wherein priming the medicament delivery device comprisesexpelling a priming portion of the medicament from the medicamentdelivery device.
 8. The medicament delivery device of claim 7, whereinthe priming portion of the medicament is between 0.05 ml and 0.2 ml. 9.The medicament delivery device of claim 1, wherein the removable cap isaxially moveable with respect to the main body, thereby allowing themedicament delivery device to be primed.
 10. The medicament deliverydevice of claim 1, wherein the removable cap comprises a snap-fitfeature configured to releasably connect to a corresponding snap-fitfeature on the delivery member shield unit.
 11. The medicament deliverydevice of claim 1, wherein the delivery member shield unit comprises adelivery member cover.
 12. The medicament delivery device of claim 11,wherein the delivery member cover extends distally and locks in anextended position after delivery of the medicament.
 13. The medicamentdelivery device of claim 11, further comprising a delivery member shieldlink coupled to the delivery member cover.
 14. The medicament deliverydevice of claim 11, wherein the delivery member cover rotates thetubular member as it moves axially in a proximal direction when a userpushes the medicament delivery device against a medicament deliverysite.
 15. The medicament delivery device of claim 14, wherein, as thetubular member turns, the tubular member releases the plunger rod whichis sitting on a second rib inside the tubular member, and wherein, whenthe plunger rod is no longer interacting with the second rib, theplunger rod can move in a distal direction to thereby cause a dose ofmedicament to be delivered.
 16. The medicament delivery device of claim1, wherein the medicament delivery device further comprises a rigidneedle shield (RNS) covering the delivery member of the medicamentdelivery device, and wherein, during removal of the removable cap fromthe medicament delivery device, the RNS is removed from the medicamentdelivery device.
 17. The medicament delivery device of claim 16, furthercomprising an RNS remover, wherein the RNS remover comprises a firstengagement feature for coupling to the removable cap and a secondengagement feature for coupling to the RNS.
 18. The medicament deliverydevice of claim 17, wherein the first engagement feature is a snap-fitfeature, and wherein the second engagement feature is a prong.
 19. Themedicament delivery device of claim 1, wherein the medicament deliverydevice is an automatic injection device.
 20. The medicament deliverydevice of claim 1, further comprising a window in the main body.